The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set for in the Professional Instructions for Use.

da Vinci Table Motion is intended to allow the surgical staff to reposition the patient by adjusting the table without undocking the da Vinci Xi Surgical System during urologic surgical procedures, general laparoscopic surgical procedures, and gynecologic laparoscopic surgical procedures. It is designed to be used with a compatible OR table.

Device Description

da Vinci Table Motion is a software-enabled feature for the da Vinci Xi Surgical System. da Vinci Table Motion allows the surgical team to reposition the patient by adjusting the operating table synchronously with, but without undocking from, the Xi surgical system. Communication between the system and the table is established through IR and RF wireless signals. There is also a wired configuration if wireless is not available.

All motion commands entered by the user on the table remote control are re-directed through the da Vinci Xi system for authorization. When paired, all table remote control button presses. instead of being sent directly from the remote control to the table motion controller in the table, are forwarded to the da Vinci Xi for approval. When the da Vinci Xi determines that the system is in a safe state for table motion to occur, the button request is forwarded to the table motion controller, and motion may then occur.

To enter da Vinci Table Motion, all instrument tips must be in view and under active control by the surgeon at the console; instruments not under active surgeon control must be removed and the table feet must be locked before the system will allow table motion.

During Table Motion, the da Vinci Xi system monitors the positioning and velocity of the Trumpf Medical TS7000dV Operating Room Table. The setup joint (SUJ) brakes release and allow the arms to passively follow table movements. The setup structure and boom actively move with the table as needed to maintain relative positioning of the remote center of each arm.

Audio and visual messaging is used to guide the user during table motion. Audio cues consist of tones and voice prompts. Visual messaging on the surgeon display, vision cart touchscreen, and table remote control, informs users of table motion status. The vision cart touchscreen display includes a tabbed interface that allows the user to adjust certain system settings, view and recover from system fault conditions, and view instructions.

AI/ML Overview

The document describes the da Vinci Xi Surgical System with Table Motion. The acceptance criteria and the study proving it meets these criteria are outlined primarily in the "Performance Data" and "Human Factors and Usability Testing" sections.

Here's an analysis of the provided text to extract the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Outcome Desired	Reported Device Performance
Software Functionality	User interface, algorithm, and software verification.	Software testing included user interface, algorithm, and software verification testing. No specific performance metrics are given beyond stating it "passed."
Electrical Safety & EMC	Conformance to recognized standards for electrical safety and electromagnetic compatibility.	Electrical safety and EMC testing were conducted by outside labs and in conformance to recognized standards.
Clinical Performance (Safety)	At least as safe as the current manual method of table motion. No issues of safety or effectiveness identified. Residual risk at acceptable levels. Use-safety not diminished compared to non-integrated process.	- Porcine model assessment: the IOTM method is "at least as safe as the current manual method of table motion."- Successfully passed all test cases in design validation testing, identifying "no issues of safety or effectiveness and no new risks." - Surgeon evaluators scored the safety of performing surgery using IOTM at a Likert score of 3 or above (passing). - Human factors testing concluded "residual risk is at acceptable levels, and that the use-safety of the system has not diminished."
Clinical Performance (Efficacy/Functionality)	Clinically acceptable performance for urologic, general laparoscopic, and gynecologic laparoscopic procedures (corresponding to indications for use). Ability to complete surgical procedures, adequately expose tissues/organs, and maintain adequate external clearance while using IOTM.	- Clinical validation testing demonstrated "clinically acceptable performance."- Surgeon evaluators confirmed the ability to complete surgical procedures, adequately expose tissues and organs, and maintain adequate external clearance while using IOTM with an average Likert score of 4.7 or higher.
Usability/Human Factors	Low user error rate, acceptable user experience. Safe and effective when used by intended users in the intended use environment.	- Summative usability validation studies involved typical workflow and troubleshooting scenarios.- Objective data included observations of users' ability to complete tasks, use-errors, close calls, and difficulties. Subjective feedback collected.- Results provided evidence that the system is "safe and effective when used by the intended users in the intended use environment." (No specific metric provided for "low user error rate" but implied by "safe and effective").
Design Validation	Successful completion of all test cases (pairing & basic functionality, intraoperative table motion, surgical performance, foreseeable clinical misuse, egress and transport, user interactions).	The da Vinci Xi Surgical System with Table Motion "successfully passed all test cases" in design validation testing.
Substantial Equivalence	Demonstrates substantial equivalence to the predicate device (da Vinci Xi Surgical System, K131861).	Performance data demonstrated the subject device is "substantially equivalent to the predicate device." Final summary states this device "is substantially equivalent" based on all data.

2. Sample Size Used for the Test Set and Data Provenance

Design Validation Testing (Clinical Engineers):
- Sample Size: One porcine model, one cadaver, and various dry/inanimate models.
- Data Provenance: Not explicitly stated, but implies animal, cadaver, and inanimate models used in a lab setting ("across three labs"). This is prospective testing on models.
Surgeon Evaluation Testing:
- Sample Size: Porcine model (number not specified), cadaver model (number not specified).
- Data Provenance: Not explicitly stated, but implies animal and cadaver models used in a lab setting ("across six labs"). This is prospective testing on live and cadaveric models.
Human Factors and Usability Testing:
- Sample Size: A minimum of fifteen surgical teams participated in each of the two summative usability validation studies (total of at least 30 teams). Each team comprised a surgeon, operating room staff, and an anesthesiologist.
- Data Provenance: Simulated OR environment, implying prospective data collection in a controlled lab setting.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Design Validation Testing (Clinical Engineers): Performed by "clinical engineers." No specific number or further qualifications are given.
Surgeon Evaluation Testing: Six independent, external surgeons.
- Qualifications: Representing four different surgical specialties: Gynecological Oncology, Urology, Colorectal, and General Surgery. No specific experience level (e.g., "10 years of experience") is provided.
Human Factors and Usability Testing: Users included "surgeons, operating room staff, and anesthesiologists."
- Qualifications: Surgeons from different surgical specialties (urology, gynecology, general surgery, and colorectal). No specific experience level is provided.

4. Adjudication Method for the Test Set

The document does not describe a formal "adjudication method" in the sense of resolving disagreements among experts to establish ground truth.

For the Surgeon Evaluation Testing, surgeons provided individual Likert scores. The reporting focuses on the collective "average Likert score," suggesting individual evaluations were aggregated rather than adjudicated to reach a singular "ground truth" per case. They all "found that the IOTM method is at least as safe" and confirmed the abilities.
For Human Factors and Usability Testing, objective performance data (observations of task completion, use-errors, close calls) and subjective feedback were collected. This was aggregated to assess overall usability and safety.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

Yes, a form of comparative effectiveness study was done in the "Surgeon Evaluation Testing."

Comparison: The IOTM method (subject device) was compared against the "current manual method of table motion."
Effect Size (Improvement):
- Safety: Surgeons found the IOTM method "is at least as safe" as the manual method. While not a quantitative improvement, it demonstrates non-inferiority in safety.
- Efficacy/Functionality: For the ability to complete surgical procedures, adequately expose tissues and organs, and maintain adequate external clearance, surgeons yielded an average Likert score of 4.7 or higher. The Likert scale was 1-5, where 3 was considered passing. This suggests a strong positive assessment of the IOTM method's functionality, though a direct "improvement effect size" against the manual method (e.g., "human readers improve X% with AI") is not quantitatively provided in this context. The manual method's Likert score is not given for comparison, only that the IOTM passed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

The device is an "Endoscopic Instrument Control System" that integrates "Table Motion" functionality. This isn't an AI diagnostic algorithm, but rather a system that assists surgical teams. The evaluation inherently involves a human-in-the-loop (surgeon, OR staff) as the device's function is to assist surgical procedures. Therefore, a "standalone algorithm only" performance study in the typical sense of AI diagnostics would not be applicable or described here. The "software testing" mentioned would be an internal, component-level evaluation, not a clinical standalone performance.

7. The Type of Ground Truth Used

The ground truth for evaluating the device's performance evolved based on the type of testing:

Design Validation Testing: Likely engineering specifications, design input requirements, and safety/effectiveness goals defined by the manufacturer, evaluated by clinical engineers. "Successful passing of all test cases" against these internal criteria serves as the ground truth.
Surgeon Evaluation Testing: Expert consensus/judgment by the six independent surgeons was the primary ground truth. Their Likert scores and qualitative assessment of safety and ability to perform tasks formed the basis.
Human Factors and Usability Testing: A combination of objective observation of user performance (e.g., successful task completion, presence/absence of errors) against pre-defined success criteria, and subjective expert feedback from the surgical teams, served as ground truth for usability and use-related risks.

8. The Sample Size for the Training Set

This document describes a 510(k) submission for a surgical system with a new feature (Table Motion). It is not an AI/ML device in the sense that it relies on a "training set" to learn and perform a task (e.g., classify images). The "Table Motion" feature is a software-enabled control system.

Therefore, the concept of a "training set" as understood in machine learning is not applicable here and is not mentioned or described in the document. The system is designed and tested against specifications rather than 'trained' on data.

9. How the Ground Truth for the Training Set Was Established

As above, the concept of a "training set" is not applicable to this device and its evaluation as described.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 15, 2016

Intuitive Surgical Incorporated Mr. Brandon Hansen Project Manager, Regulatory Affairs 1266 Kifer Road Sunnyvale, California 94086

Re: K151794

Trade/Device Name: da Vinci Xi Surgical System with Table Motion Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NAY Dated: December 29, 2015 Received: December 30, 2015

Dear Mr. Hansen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K151794

Device Name da Vinci Xi Surgical System with Table Motion

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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FORM FDA 3881 (8/14)

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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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510(k) Summary

510(k) Owner:	Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086
Contact:	Brandon HansenRegulatory AffairsPhone Number: 408-523-7485Fax Number: 408-523-8907Email: brandon.hansen@intusurg.com
Date Summary Prepared:	January 13, 2016
Trade Name:	da Vinci® Xi Surgical System with Table Motion
Common Name:	Endoscopic instrument control system,endoscopic instruments and accessories
Classification:	Class II21 CFR 876.1500, Endoscope and Accessories
Product Codes:	NAY (System, Surgical, Computer Controlled Instrument)
Classification AdvisoryCommittee:	General and Plastic Surgery
Predicate Device:	da Vinci® Xi Surgical System device, K131861

Device Description

Image /page/3/Picture/7 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and in a light gray color. Below that, the word "SURGICAL" is in a smaller font and also in a light gray color, with the registered trademark symbol to the right.

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Intended Use/Indications for Use:

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

Technological Characteristics:

In terms of intended use, indications for use, and technological characteristics, the da Vinci Xi Surgical System with Table Motion is substantially equivalent to the currently marketed da Vinci Xi Surgical System device, cleared under K131861.

Image /page/4/Picture/10 description: The image contains the logo for Intuitive Surgical. The word "INTUITIVE" is in a larger, sans-serif font above the word "SURGICAL" which is in a smaller font. There is a small yellow dot above the word "INTUITIVE".

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Performance Data:

Performance test data demonstrate that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements. The testing conducted consisted of software, electrical safety, EMC, human factors and simulated use in animal models.

The software testing included user interface, algorithm and software verification testing. Electrical safety and EMC testing were conducted by outside labs and in conformance to recognized standards. Multiple clinical validation studies were conducted using animal, cadaver and inanimate models. This testing included actual surgical procedures from the three surgical specialties in the indications for use statement. External surgeons were used for a portion of this testing. The clinical validation testing demonstrated clinically acceptable performance of the da Vinci Xi Surgical System with Table Motion and substantial equivalence to the predicate da Vinci Xi Surgical System.

Simulated use testing consisted of design validation testing using clinical engineers and surgeon evaluation studies using external surgeons. Design Validation testing by clinical engineers was completed across three labs utilizing one porcine model, one cadaver, and dry/inanimate models. The porcine model was used for test cases requiring live tissue interaction (such as for port site retention and trauma assessment). The cadaver was used for those test cases that required realistic human anatomy, such as for patient positioning and access and patient clearance. Inanimate models were used for those interactions that occur before or after surgery for those features and mitigations that do not affect system surgical use. Tests cases were grouped into the following categories: pairing and basic functionality, intraoperative table motion, surgical performance, foreseeable clinical misuse, egress and transport and user interactions. The da Vinci Xi Surgical System with Table Motion successfully passed all test cases. Furthermore, this testing identified no issues of safety or effectiveness and no new risks.

Surgeon evaluation testing was completed across six labs, utilizing porcines and cadavers. The porcine model was used to assess whether the IOTM method is at least as safe as the current manual method of table motion. Different procedural tasks, corresponding with changes in patient positions, formed the basis of comparison between the manual and the IOTM (subject device) method. The cadaver model was used to confirm the ability to complete surgical procedures, the ability to adequately expose tissues and organs, and the ability to maintain adequate external clearance while using IOTM. Different procedures (and target anatomies), corresponding with changes in patient positions, facilitated evaluation of the testers' ability to complete these procedures while using ITOM. Six independent, external surgeons, representing four different surgical specialties (Gynecological Oncology, Urology, Colorectal, and General Surgery), served as evaluators for the comparative assessments. Upon completion of testing, surgeon evaluators graded the safety and efficacy of performing surgery using intraoperative table motion for both the porcine and cadaveric evaluations. A Likert score (scaled from one to

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five, where a score of three was considered passing) was assigned for each of the attributes. The da Vinci Xi Surgical System with Table Motion successfully passed all requirements as described in the protocol. All surgeons found that the IOTM method is at least as safe as the current manual method of table motion (i.e., scored 3 or above). In addition, with an average Likert score of 4.7 or higher, surgeons confirmed the ability to complete surgical procedures, the ability to adequately expose tissues and organs, and the ability to maintain adequate external clearance while using IOTM.

Human Factors and Usability Testing:

The Human Factor engineering process, culminating in usability validation studies, was utilized to identify and assess the use-related risks associated with da Vinci Xi Surgical System with Table Motion. The safety and usability of the da Vinci Xi Surgical System with Table Motion was assessed to ensure residual risk is at acceptable levels, and that the use-safety of the system has not diminished in comparison to the non-integrated process of moving the operating table during da Vinci surgeries. Two summative usability validation studies were conducted with users (surgeons, operating room staff, and anesthesiologists) for the da Vinci Xi Surgical System with Table Motion. A simulated OR environment including equipment and sound provided realistic conditions for the testing. The studies involved typical workflow scenarios, as well as certain troubleshooting scenarios related to safety-critical tasks.

A minimum of fifteen surgical teams with surgeons from different surgical specialties (urology, gynecology, general surgery and colorectal) participated in each summative study. A surgeon, operating staff, and an anesthesiologist comprised a surgical team. Each participant received hands-on training prior to conducting testing. Users performed essential tasks including identification of compatible equipment, pairing of system and table, activating table motion, moving the table using the table remote, and troubleshooting scenarios. Data collected included both objective performance data and subjective feedback from participants. Objective performance data included observations of users' ability to complete tasks, use-errors, close calls, and any difficulties encountered. Subjective feedback included open-ended questions about risks and safety, multiple choice ratings, and follow-up interviews. Results of the validation studies and the other elements of the human factors engineering program provided evidence that the da Vinci Xi Surgical System with Table Motion is safe and effective when used by the intended users in the intended use environment. .

Summary:

Based on the intended use, indications for use, technological characteristics, and performance data, the da Vinci Xi Surgical System with Table Motion is substantially equivalent to the currently marketed da Vinci Xi Surgical System device, cleared under K131861.

Image /page/6/Picture/8 description: The image contains the logo for Intuitive Surgical. The word "INTUITIVE" is in a sans-serif font, with a yellow dot above the "I". Below that, in a smaller font, is the word "SURGICAL" followed by the registered trademark symbol.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.